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Acarix receives US market approval for the CADScor® System 

Acarix AB (publ) today announced that the US Food and Drug Administration (FDA) has approved the company’s De Novo application for marketing approval of the CADScor®System in the US.

 

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About Acarix
Acarix is a Swedish medical device company that innovates solutions for rapid AI-based rule out of Coronary Artery Disease (CAD). The CE approved and FDA DeNovo cleared Acarix CADScor®System is intended for patients experiencing chest pain with suspected CAD and designed to help reduce millions of unnecessary, invasive and costly diagnostic procedures. The CADScor system calculates a patient-specific CAD-score non-invasively in less than10 minutes and can help rule out more than one third of patients with at least 96% certainty of not being sick (in a population with approx. 10% CAD prevalence). Acarix is listed on the Nasdaq First North Premier Growth Market (ticker: ACARIX). Redeye AB (+46 (0)8 121 576 90, certifiedadviser@redeye.se) is Certified Advisor of Acarix.

For more information, please visit www.acarix.com.